Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K083544 |
Device Name |
KAT IMPLANT SYSTEM |
Applicant |
KAT IMPLANTS, LLC |
15 RYE STREET |
SUITE 115 |
PORTSMOUTH,
NH
03801
|
|
Applicant Contact |
VITALI BONDAR |
Correspondent |
KAT IMPLANTS, LLC |
15 RYE STREET |
SUITE 115 |
PORTSMOUTH,
NH
03801
|
|
Correspondent Contact |
VITALI BONDAR |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/28/2008 |
Decision Date | 02/02/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|